OBJECTIVE Health-related quality of life (HRQoL) is one of the most important patient-relevant study end-points for the direct measurement of the benefit of cancer drugs. Therefore, our aim is to detect cancer indications with no published information on HRQoL at the time of European Medicines Agency (EMA) approval and monitor any reported HRQoL evidence updates after at least three years of follow-up. METHODS We included all cancer indications that were approved by the EMA between January 2009 and October 2015. Our main sources of information were the EMA website, clinicaltrials.gov and a systematic literature search in PubMed. Information on HRQoL outcomes was extracted alongside evidence on median overall survival. RESULTS In total, we identified 110 indications, of which more than half (n = 58, 53%) were lacking available information on HRQoL assessments at the time of EMA approval. After a monitoring period of at least three years, 24 updates were identified, resulting in 34 (31%) therapies where information on HRQoL was still not available. For the 76 therapies with reported information on HRQoL, cancer-specific instruments were mostly used (n = 49/76). Regarding cumulative evidence on median overall survival and HRQoL, 33 (n = 33/110, 30%) as well as 15 (n = 15/110, 14%) cancer drugs were lacking information on both study end-points at the time of approval and after monitoring, respectively. CONCLUSION Our results demonstrate that there is an urgent need of routine re-evaluation of reimbursed cancer drugs with initially missing information on major outcomes. Standardisation of the typology and quality of HRQoL assessments need to be improved to allow better comparability of results.

中文翻译：

---

2009年至2015年间，欧洲药品管理局批准的与癌症药物相关的健康相关生活质量收益的公开证据。

目的与健康相关的生活质量（HRQoL）是与患者相关的最重要的研究终点之一，可直接衡量癌症药物的获益。因此，我们的目的是在获得欧洲药品管理局（EMA）批准时，在没有关于HRQoL的公开信息的情况下检测癌症适应症，并在至少三年的随访后监测所有报告的HRQoL证据更新。方法我们纳入了EMA在2009年1月至2015年10月之间批准的所有癌症适应症。我们的主要信息来源是EMA网站，clinicaltrials.gov和在PubMed中进行的系统文献检索。提取了关于HRQoL结果的信息以及中位总体生存率的证据。结果我们总共确定了110种适应症，其中一半以上（n = 58）53％）在EMA批准时缺乏有关HRQoL评估的可用信息。在至少三年的监视期后，确定了24种更新，导致34种（31％）疗法无法获得有关HRQoL的信息。对于报告了有关HRQoL信息的76种疗法，大多数使用了针对癌症的仪器（n = 49/76）。关于中位总体生存率和HRQoL的累积证据，截至2007年11月，有33种（n = 33/110，30％）以及15种（n = 15/110，14％）癌症药物缺乏这两种研究终点的信息。批准和监督之后。结论我们的结果表明，迫切需要对已报销的癌症药物进行常规的重新评估，而最初缺少有关主要结果的信息。